Medical Device Manufacturer · US , Largo , FL

Smith & Nephew United, Inc.

34 submissions · 23 cleared · Since 1989
34
Total
23
Cleared
0
Denied

Smith & Nephew United, Inc. — FDA 510(k) Submissions

Smith & Nephew United, Inc. has submitted 34 FDA 510(k) premarket notifications since 1989, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bandage, Liquid, Tape And Bandage, Adhesive, Beads, Hydrophilic, For Wound Exudate Absorption, Dressing, Wound, Hydrogel Without Drug And/or Biologic, Dressing, Wound, Occlusive . Use the specialty filter in the sidebar to narrow results.

34 devices
1–12 of 34
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
K963096 · KMF Bandage, Liquid · General & Plastic Surgery
Oct 1996 77d
PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
K961775 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Jul 1996 69d
ALLEVYN ADHESIVE
K945330 · KMF Bandage, Liquid · General & Plastic Surgery
Feb 1995 100d
CAVI-CARE CONFORMING FOAM DRESSING
K943619 · KMF Bandage, Liquid · General & Plastic Surgery
Aug 1994 23d
INTRASITE
K942748 · NAE Dressing, Wound, Hydrogel... · General & Plastic Surgery
Jun 1994 19d
ALLEVYN ISLAND WOUND DRESSING
K935705 · NAE Dressing, Wound, Hydrogel... · General & Plastic Surgery
Feb 1994 77d
CICA-CARE SILICONE GEL SHEET
K935803 · MDA Elastomer, Silicone, For... · General & Plastic Surgery
Feb 1994 63d
SOLOSITE DERMAL WOUND GEL
K932263 · MGQ Dressing, Wound And Burn,... · General & Plastic Surgery
Oct 1993 164d
INTRASITE GEL
K926508 · NAE Dressing, Wound, Hydrogel... · General & Plastic Surgery
Jul 1993 195d
STRAPPAL
K922897 · KGX Tape And Bandage, Adhesive · General & Plastic Surgery
Sep 1992 91d
ALLEVLYN WOUND DRESSING, MODIFICATION
K914147 · KMF Bandage, Liquid · General & Plastic Surgery
Feb 1992 140d
REMOVE ADHESIVE REMOVER
K915150 · KOX Solvent, Adhesive Tape · General & Plastic Surgery
Jan 1992 56d
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